RLY-1971 in Subjects With Advanced or Metastatic Solid Tumors

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called RLY-1971 in patients with advanced or spreading cancers. It aims to find the safest dose, understand how the drug is processed by the body, and see if it can shrink tumors.

Eligibility Criteria

Inclusion Criteria

Subject is willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures Subject is a male or female subject ≥18 years of age at the time of consent Subject must have an ECOG PS ≤ 1 Subject must have histologically or cytologically confirmed advanced or metastatic solid tumor Subjects who are refractory to FDA-approved, standard therapy or for which standard or curative therapy does not exist or is not considered sufficient or appropriate by the patient or Investigator Subject must have radiographically measurable or evaluable disease Subject must have recovered from the reversible effects of prior anti-neoplastic therapy, except for alopecia and ≤ grade 2 neuropathy.

Subject has adequate end organ function Subject is willing to comply with all protocol-required visits, assessments, and procedures Male and female subjects of child-bearing potential are willing to use medically acceptable methods of birth control from the screening visit through 30 days after the last dose of study medication

Treatment Details

Interventions

RLY-1971 (Cancer Metabolism Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: RLY-1971 - Dose Escalation/ExpansionExperimental Treatment1 Intervention

Dose Escalation: Oral dose of RLY-1971 until Maximum Tolerated Dose (MTD), and Recommended Phase 2 dose (RP2D) are identified Dose Expansion: Oral dose of RLY-1971 once Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D) are identified.